8 Jun 2016
Innovus Pharmaceuticals announced today that its partner Khandelwal Laboratories filed the product licenses for Zestra®, Zestra Glide®, EjectDelay® and Sensum+® with the Indian FDA, The Drugs Controller General (India) and the Directorate General of Health Services to commercialize the products in India.
The process is expected to take between 120 to 180 days pending any questions from the Indian government.
On September 10, 2015 Innovus Pharma entered into an exclusive marketing and distribution agreement with Khandelwal Laboratories based in India (“KLab”) under which Innovus Pharma has granted to KLab an exclusive ten-year license and distribution rights to market and sell some of Innovus Pharma’s products including: Zestra® to increase Female Sexual Arousal and Desire and Satisfaction, EjectDelay® for treating premature ejaculation, Sensum+® to increase penile sensitivity and Zestra Glide® the high viscosity water based lubricant. If KLab exceeds its minimum yearly orders, the agreement has two five-year term extensions. Under the agreement, the minimum orders for the first term of the agreement are over two million and six hundred thousand ($2.6M) US dollars.”
About Zestra® and FSI/AD
Zestra® is a patented blend of natural oils clinically-proven in double-blind placebo-controlled clinical trials in 276 women to increase in a statistical significant manner the arousal, desire and sexual satisfaction in FSI/AD women. Zestra® is the first NHP product to receive approval for the indication of FSI/AD in Canada as an NHP. To date, the Company believes that no product has been approved to treat FSI/AD, a persistent or recurring inability to attain or maintain adequate sexual excitement until the completion of a sexual activity. The diagnosis can also refer to an inadequate lubrication-swelling response normally present during arousal and sexual activity causing personal distress. Published papers on the FSI/AD market size estimate it to be equal or larger than the market for erectile dysfunction in males, and possibly larger. Zestra® is currently available in the United States, Canada and Morocco. For more information visit www.zestra.com.
About EjectDelay® and Premature Ejaculation
EjectDelay® is an over-the-counter (“OTC”) U.S. Food and Drug Administration and Health Canada compliant proprietary topical treatment containing the drug benzocaine and indicated for treatment of premature ejaculation. The drug typically works within minutes of application to the glans of the penis. In clinical trials, the application of benzocaine has been shown to delay premature ejaculation by several minutes. For more information visit www.ejectdelay.com.
Premature ejaculation (“PE”) is the most common sexual dysfunction reported by men but is still under-diagnosed and under-treated. PE can happen at any age and its prevalence is consistent across all ages. In an article in The Journal of Sexual Medicine in 2007 Sex Med 2007, D.L. Patrick, D. Rowland and M. Rothman stated, “Global studies consistently report that 20-30% of men experience PE worldwide.”
About Sensum+® and Reduced Penile Sensitivity (RPS)
Sensum+® is a patented blend of essential oils and natural botanicals including rose oil, sweet almond oil, cinnamon bark oil, and other extracts. The main ingredient of Sensum+® (cinnamon oil) works by activating the Transient Receptor Potential A1 (TRPA-1) channels responsible for the heat and cold sensation of the skin and results in an increase of sensation that current users welcome and appreciate. The safety and efficacy of Sensum+® was evaluated in 2 post marketing survey studies in circumcised and non-circumcised men. A total of 382 men used Sensum+® twice daily for fourteen consecutive days followed by once daily for 8 weeks and as needed thereafter.
Reduced penile sensitivity is a major problem associated with many diseases such as hernia surgery, the use of anti-depressants, circumcision, multiple sclerosis and others. There are no approved products to treat RPS. For more information visit www.sensumplus.com.
About Innovus Pharmaceuticals, Inc.
Headquartered in San Diego, Innovus Pharma is an emerging leader in OTC and consumer products for men’s and women’s health and vitality. The Company generates revenues from its lead products (a) BTH® Testosterone Booster, (b) BTH® Human Growth Agent, (c) Zestra® for female arousal and (d) EjectDelay® for premature ejaculation and has an additional five marketed products in this space, including (e) Sensum+® for the indication of reduced penile sensitivity, (for sales outside the U.S. only), (f) Zestra Glide®, (g) Vesele® for promoting sexual and cognitive health, (i) Androferti® (in the U.S. and Canada) to support overall male reproductive health and sperm quality, (j) BTH Vision Formula, (k) BTH Blood Sugar, among others and eventually FlutiCare™ OTC for Allergic Rhinitis, if its ANDA is approved by the U.S. FDA.